FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90217–90240 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 1998
PLANCON MICROLAMELLAR KERATOME EVOLUTION
K980924 · HNO
Plancon Instruments
Ophthalmic · 35d
Cleared Apr 15, 1998
NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
K980991 · CHL
Nova Biomedical Corp.
Chemistry · 29d
Cleared Apr 15, 1998
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
K981051 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 28d
Cleared Apr 15, 1998
STRATUS CS MYO CALPAK
K981101 · JIT
Dade Behring, Inc.
Chemistry · 20d
Cleared Apr 14, 1998
MUSCLE RESPONSE MONITOR
K971400 · HCC
Enriching Your Life
Neurology · 364d
Cleared Apr 14, 1998
PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE
K972201 · DXZ
Sulzer Carbomedics, Inc.
Cardiovascular · 307d
Cleared Apr 14, 1998
RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
K972546 · JOH
Rusch Intl.
Anesthesiology · 280d
Cleared Apr 14, 1998
BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR
K972783 · MAI
Bionx Implants, Inc.
Orthopedic · 263d
Cleared Apr 14, 1998
CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER
K973613 · DXN
Foley & Lardner
Cardiovascular · 204d
Cleared Apr 14, 1998
ENVOY PATIENT MONITOR
K974510 · DSI
Mennen Medical, Inc.
Cardiovascular · 134d
Cleared Apr 14, 1998
UNIVERSITY PLATE ANTERIOR SYSTEM
K980228 · KWQ
Acromed Corp.
Orthopedic · 82d
Cleared Apr 14, 1998
DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM
K980368 · HRS
Depuy, Inc.
Orthopedic · 74d
Cleared Apr 14, 1998
BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR
K980370 · KTT
Biomet, Inc.
Orthopedic · 74d
Cleared Apr 14, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K980447 · MNH
DePuy Orthopaedics, Inc.
Orthopedic · 68d
Cleared Apr 14, 1998
IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM
K980486 · JDI
Implex Corp.
Orthopedic · 64d
Cleared Apr 14, 1998
WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER
K980496 · MNH
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Apr 14, 1998
ARTICUL/EZE FEMORAL HEADS
K980513 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Apr 14, 1998
DENOPTIX BARRIER ENVELOPE (SIZE 0-4)
K980543 · EHD
Dentsply Intl.
Radiology · 61d
Cleared Apr 14, 1998
AR SAFE NITRILE EXAMINATION GLOVES
K980589 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 56d
Cleared Apr 14, 1998
LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE)
K980605 · LYY
Pt. Sarana Indoprotex
General Hospital · 56d
Cleared Apr 13, 1998
YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
K980147 · LPN
Automatic Liquid Packaging, Inc.
Ophthalmic · 88d
Cleared Apr 13, 1998
PREMIER 7000 CTL SPINE COIL
K980157 · MOS
Usa Instruments, Inc.
Radiology · 87d
Cleared Apr 13, 1998
HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS
K980169 · JAK
General Electric Co.
Radiology · 87d
Cleared Apr 13, 1998
HISPEED QX/I CT SCANNER SYSTEM
K980176 · JAK
General Electric Co.
Radiology · 83d